FDA recall D-0417-2015

Hospira Inc. · Class II · drug

Product

5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), UPC (01)0030404097100026; packaged in 24 bags per case pack (NDC 0409-7100-02), UPC (01)30304097100027(30)01, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045.

Reason for recall

Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2015-03-05
Report date: 2015-03-25
Termination date: 2016-12-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0417-2015